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Ovarian Hyperstimulation Syndrome and Cabergoline

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assoc. Prof. Emine Seda Guvendag Guven, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01569256
First received: March 26, 2012
Last updated: April 3, 2012
Last verified: April 2012
History of Changes
  Purpose

Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).


Condition Intervention
Polycystic Ovarian Syndrome
Ovarian Hyperstimulation Syndrome
 Drug: Cabergoline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Etlik Zubeyde Hanim Womens' Health and Teaching Hospital:

Primary Outcome Measures:
  • Concentrations of follicular fluid AMH [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concentrations of follicular fluid inhibin B [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Concentrations of follicular fluid HGF [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cabergoline administered group

The patients in this group will have cabergoline (Dostinex tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days) for prevention of OHSS.

All patients were administered long luteal protocol for ovulation induction.

 Drug: Cabergoline
Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days
Other Name: Dostinex
No Intervention: Control arm

The patients in the control group had no manipulation for prevention of OHSS and age-, BMI-matched with the active comparator group.

All patients were administered long luteal protocol for ovulation induction.

Detailed Description:

Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.

  Eligibility

Ages Eligible for Study:   23 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Development of more than 14 leading follicles larger than 10 mm and serum estradiol more than 3000 pg/ml at the end of ovulation induction with long luteal ovulation induction protocol.
  • Having the criteria of PCOS

Exclusion Criteria:

  • Not having the inclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569256

Sponsors and Collaborators
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Investigators
Study Chair: Emine Seda Guvendag Guven, MD Rize University, Faculty of Medicine
  More Information

No publications provided

Responsible Party: Assoc. Prof. Emine Seda Guvendag Guven, Assoc. Prof., Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01569256     History of Changes
Other Study ID Numbers: ESG1
Study First Received: March 26, 2012
Last Updated: April 3, 2012
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Hyperstimulation Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Cabergoline
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013